Department of Pediatrics and Neurology, University of Colorado, Anschutz Medical Campus, Aurora CO 80045, United States.
Department of Biostatistics and Informatics, University of Colorado, Anschutz Medical Campus, Aurora CO 80045, United States; Adult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO, 80045, United States.
Seizure. 2019 Nov;72:23-27. doi: 10.1016/j.seizure.2019.09.007. Epub 2019 Sep 16.
Interest in the use of artisanal cannabinoids in pediatric epilepsy has increased but safety and utility data are lacking. Our aim was to prospectively characterize the use of oral cannabis extracts (OCE) in a refractory pediatric epilepsy population.
Families considering the use of an OCE were enrolled in a prospective observational study. Baseline seizure frequency was assessed over a period of 4 weeks. Seizure frequency, CBD and THC-COOH levels were assessed every 4 weeks during a 12-week treatment period. Response was defined as at least a 50% reduction in seizure frequency over the final 8 weeks of the study relative to baseline.
Consent was obtained in 32 children; 11 were excluded from analysis (3 failed to complete baseline data, 3 started OCE before completing baseline period and 5 did not start OCE) leaving 21 to be included in subsequent analyses. Median age was 10.3 years (IQR 6.8-12.6), 13 (62%) were male and median seizure frequency was 2.7 seizures/day during the baseline period. The median of the high dose of CBD that was administered during the observation period was of 0.9 (0.6-2.2) mg/kg/day. Of the 21 subjects who were included in the analysis, 5 (24%) were responders. OCE was stopped early in 3 subjects (14%) due to a perceived increase in seizures. THC-COOH and CBD blood levels did not have a significant association with response status (p = 0.95 CBD, p = 0.53 THC-COOH, N = 14).
The observed response rate in this study is similar to placebo rates in prospective randomized trials of pharmaceutical grade products and the withdrawal rate is greater than rates obtained with retrospective methods. Doses of OCE administered were lower than doses used in randomized trials.
人们对在儿科癫痫中使用手工大麻素的兴趣日益增加，但缺乏安全性和实用性数据。我们的目的是前瞻性地描述口服大麻素提取物（OCE）在难治性儿科癫痫人群中的应用。
考虑使用 OCE 的家庭被纳入前瞻性观察性研究。在 4 周的时间内评估基线发作频率。在 12 周的治疗期间，每 4 周评估一次发作频率、CBD 和 THC-COOH 水平。反应定义为与基线相比，研究的最后 8 周内发作频率至少降低 50%。
在 32 名儿童中获得了同意；11 名被排除在分析之外（3 名未能完成基线数据，3 名在完成基线期之前开始使用 OCE，5 名未开始使用 OCE），其余 21 名被纳入后续分析。中位年龄为 10.3 岁（IQR 6.8-12.6），13 名（62%）为男性，基线期的中位发作频率为 2.7 次/天。在观察期内给予的 CBD 高剂量的中位数为 0.9（0.6-2.2）mg/kg/天。在纳入分析的 21 名受试者中，有 5 名（24%）为应答者。由于认为发作增加，3 名（14%）受试者提前停止使用 OCE。THC-COOH 和 CBD 血药水平与反应状态无显著相关性（p=0.95 CBD，p=0.53 THC-COOH，N=14）。
在这项研究中观察到的反应率与前瞻性随机试验中药物级产品的安慰剂率相似，停药率高于回顾性方法获得的比率。给予的 OCE 剂量低于随机试验中使用的剂量。
